The FDA has published final Postmarket Cybersecurity guidance for
connected medical devices, which is the agency’s latest guidance to
compliment the 2014 document on pre-market cybersecurity management and
FDA notifications. Device manufacturers are now advised to produce and
implement a structured and comprehensive program to manage cybersecurity
risks throughout the product lifecycle, while continually addressing
vulnerabilities before they can be exploited and cause harm. With the
ever-shifting risks associated with connected device cybersecurity on
the rise, manufacturers must prioritize managing risks and combatting
cyber threats. This program will include a discussion of the following:

Overview of the new FDA guidelines and background on FDA’s device regulation